(121 days)
Not Found
No
The device is a simple examination glove and the summary provides no indication of AI/ML technology.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment.
No
Explanation: The device is a non-sterile disposable glove for patient examination, intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical product (gloves) and the summary describes physical properties and testing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Intended Use: The intended use of these gloves is to be worn on the examiner's hand or finger to prevent contamination between the patient and examiner. This is a barrier function, not a diagnostic test performed on a specimen.
- Device Description: The description focuses on the physical properties and standards met by the gloves, not on any diagnostic capabilities.
- Performance Studies: The performance studies focus on the physical integrity and biocompatibility of the gloves, not on the accuracy or reliability of any diagnostic results.
The device described is a Class I medical device (specifically, a patient examination glove) used for barrier protection during medical examinations. It does not perform any diagnostic testing on patient specimens.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical data:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.
Key results:
Dimension: Meets ASTM standard D 5250-06 el.
Physical Properties: Meets ASTM standard D 5250-06 el.
Freedom from pinholes: Meets 21 CFR 800.20
Powder Residual: Meets ASTM standard D 5250-06 el and D6124-06 (
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Section C 510(k) Summary (21 CFR 807.92)
510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AUG - 6 2010
Premarket Notification [510(k)] Summary
· · ·
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Hebei Shenzichen Plastic& Rubber Products Co.,Ltd. |
|---|---|
| Submitter's address : | Ciyutuo Development Area,Luan County,Tangshan |
| City,Hebei Province,063100,China | |
| Phone number : | 86-315-5028919 |
| Fax number : | 86-315-5028919 |
| Name of contact person: | Mr.Xu Gang |
| Date the summary was prepared: | Mar 19, 2010 |
[{a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves,
Clear (non-colored) |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves,
Clear (non-colored)
Other clients private labeling |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Section C
1
Predicate device: FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
Device Description: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
{{a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Vinyl Patient Examination Gloyes, Clear (non-colored), non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 el | |
| and D6124-06 | Meets |